FDA News

On March 5, Scott Gottlieb, M.D., announced he will be stepping down as Commissioner of FDA. His resignation will become effective in about one month. His two-year tenure, since May 2017, has been very productive. Gottlieb spearheaded initiatives on a variety of complex issues, including …

Waaaaayyyy back in 2012, when life (and practicing food and drug law) was simpler, something caused us to study and evaluate the year-over-year change (i.e., the change in girth by the number of pages) in Title 21 of the Code of Federal Regulations (“CFR”) from …

By Ricardo Carvajal & Kurt R. Karst –
According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …

By Kurt R. Karst –
FDA’s Office of Generic Drugs (“OGD”) will have a new leader beginning next week. On July 13th, Helen Winkle, Director of the Office of Pharmaceutical Science in the Center for Drug Evaluation and Research, in which OGD is housed, announced that Gregory …

On February 29th, FDA Commissioner Margaret A. Hamburg, M.D. announced in an FDA-wide e-mail the permanent appointment of Elizabeth H. Dickinson as FDA’s Chief Counsel. Ms. Dickinson has served as FDA’s Acting Chief Counsel since August 7, 2011 (see our previous post). Prior to that …

By Kurt R. Karst –
We have learned that FDA’s Office of Orphan Products Development (“OOPD”) has a new Acting Director. Debra Lewis, O.D., M.B.A., who is OOPD Deputy Director, and who has been serving as Acting Director since the Departure of Dr. Timothy Coté earlier …

FDA Law Blog has learned that Elizabeth H. Dickinson, who currently serves as Associate Chief Counsel for Drugs in FDA’s Office of Chief Counsel, will serve as FDA’s Acting Chief Counsel effective on August 7th. As we previously reported, FDA’s current Chief Counsel, Ralph Tyler, recently …

About 18 months after coming to FDA to serve as Chief Counsel, Ralph Tyler will be leaving the Agency, according to an FDA-wide e-mail sent out on June 30th by FDA Commissioner Margaret Hamburg. Prior to joining FDA, Mr. Tyler served as Insurance Commissioner of …

By John R. Fleder –
For over forty years there has been a unit in the Department of Justice dedicated to representing FDA in court actions. Originally housed in the Antitrust Division under the name “Consumer Affairs Section”, the office was moved to DOJ’s Civil Division …

June Stephenson, a 37-year employee in FDA’s Office of Chief Counsel, will retire on December 31, 2010. Ms. Stephenson has been the principal secretary for every chief counsel at FDA since 1974. At a December 8th retirement party, her contributions were recognized by almost all …

By William T. Koustas —
The FDA has announced that it will require all drugs known as Erythropoiesis-Stimulating Agents (“ESAs”) to have a Risk Evaluation and Mitigation Strategy (“REMS”). At the present time, this class of drugs is limited to three Amgen products: Procrit, Epogen (both …

By Kurt R. Karst –
Earlier today, FDA Commissioner Dr. Margaret Hamburg announced in an Agency-wide e-mail that Ralph S. Tyler has been appointed to serve as FDA’s Chief Counsel. Mr. Tyler, who is currently serving as Insurance Commissioner of the State of Maryland, will …

By Jamie K. Wolszon – FDA has announced the establishment of a cross-agency task force to craft recommendations on how to increase transparency regarding the agency’s operations, activities, processes and decisionmaking, including product approvals, enforcement actions, and product recalls, while protecting confidential information. The agency …

By Kurt R. Karst –
On May 18th, the U.S. Senate confirmed (by voice vote) President Obama’s pick to head FDA – Dr. Margaret Hamburg. Among other things, Dr. Hamburg has worked extensively on bioterrorism issues. For six years in the 1990s, Dr. Hamburg served …

By Kurt R. Karst –
We learned earlier today that Michael M. Landa, Esq. was named as FDA’s new Acting Chief Counsel. Mr. Landa, who will assume his new role on April 13, 2009, has a long history with FDA. Since July 2004, Mr. Landa …